Blood Plasma Trial Gets Into Nitty-Gritty

SAN DIEGO (CN) — Jurors on Monday heard a he said-she said battle in an employee whistleblower trial against a San Diego-based medical laboratory, as conflicting arguments painted a murky picture of blood plasma protocols. The case was brought by former Scantibodies Laboratory employees Janette Nolasco and Brenda Taylor, who claim they were retaliated against for trying to comply with U.S. Food and Drug Administration guidelines for collecting blood plasma. Nolasco and Taylor say Scantibodies side-stepped FDA rules for collecting blood plasma by transporting and selling “specialty plasma” — which is collected from donors with diseases — without the proper licensing to do so. The company also allegedly relabeled specialty plasma originally identified “for research use only” when it was transferred from the blood plasma collection lab to Scantibodies’ other location, where a new label with “research or manufacture use” was stuck on the diseased plasma. Scantibodies has been investigated multiple times by the FDA, but has not been fined or cited. The company does have a restricted license for collecting blood plasma, however, and can no longer collect specialty plasma, according to Nolasco and Taylor’s attorney, Clarice Letizia. One sale of highly sought-after specialty plasma was sold by Scantibodies for more than $1 million, which counteracts the company’s story that it was not making enough money and had to eliminate Nolasco’s position, the plaintiffs claim. But Scantibodies claimed the biologics center where the plasma was collected was losing more than $100,000 a month by the time they decided to fire Nolasco, who was the center manager and made more than double what other employees at the plasma center made. On Monday, Scantibodies produced a spreadsheet detailing how much money the company made off specialty plasma sales collected at the plasma center when Nolasco and Taylor worked there. According to the spreadsheet, there were no million-dollar sales, as the plaintiffs have maintained throughout the trial. Before the jury was brought in, counsel on both sides argued how the spreadsheet was created, with Letizia suggesting the document was “conjured up.” “This is not the real evidence,” Letizia told San Diego Superior Court Judge Gregory Pollack. But Pollack did require Scantibodies produce documents detailing how it came up with the dollar figures and one of its employees, Marina Bradley, was brought in to testify for a second time. Bradley, who works as a controller for the company, told the jury that between June 2011 and August 2013, Scantibodies only made $207,000 on specialty plasma sales collected from the center Nolasco and Taylor worked at. Another current Scantibodies employee, Rebecca Winter, testified that Taylor and Nolasco knew the specialty plasma labels would be relabeled and reclassified once the plasma was transferred to the company’s other location and they had no objections. The plasma received a new part number and was relabeled, Winter said. But when Winter was pressed specifically about the plasma being relabeled from “research use only” to “research or manufacturer use,” she told the jury, “It wouldn’t be my place to say anything about that.” While Nolasco was fired, Taylor stayed with the company but claims she was retaliated against by her former supervisor, Michael Nordstrom. She says she went to Human Resources Director Ann Marie Cadenhead multiple times with complaints about how she was treated following FDA inspections and investigations. But Cadenhead never conducted an HR investigation into Taylor’s harassment complaints made in 2011, 2012 and 2013. In her deposition, Cadenhead told Letizia she thought “making someone uncomfortable could be interpreted as harassment.” Leticia fired off a lengthy list of Scantibodies employees who told Cadenhead that Nordstrom “was difficult to work for” and had “people in tears,” among other comments. “It was common knowledge the two of them didn’t get along,” Cadenhead said. Letizia told the jury that Scantibodies did not investigate Taylor’s harassment complaints until after they received a right to sue notice from the labor board. In the end, Scantibodies’ internal investigation found Taylor had not been harassed. Taylor was eventually “stripped” of many of her duties and was excluded from meetings and interviews of potential employees. She was also eventually denied building access privileges and had to be escorted from building to building, Letizia said. Taylor was retaliated against for “her refusal to violate FDA regulations,” Letizia told the jury. When Scantibodies attorney Vince Verde questioned Cadenhead, he pointed out other comments made during the HR investigation, such as one employee who said Taylor “tends to see the glass half empty and takes a negative spin on things.” Another employee said they were “surprised” by Taylor’s allegations because the “mood of the department was upbeat,” Verde said. Closing arguments were expected to be heard Tuesday.